title: Treatment persistence and changes in fracture risk, back pain, and quality of life amongst patients treated with teriparatide in routine clinical care in France: results from the European Forsteo Observational Study.
abstract: OBJECTIVE
  The European Forsteo Observational Study assessed the clinical fracture incidence, back pain, quality of life (QoL), and treatment persistence amongst post-menopausal women, who were prescribed teriparatide in routine care in eight European countries. We present the results for France, with health-insurance reimbursement criteria channel teriparatide to women with severe disease and limit treatment to 18 months.
  
  
  METHODS
  A representative sample of women initiating teriparatide in France was followed in routine care for 36 months. We described patients' characteristics at baseline and persistence to teriparatide (Kaplan-Meier analysis), fracture incidence, back pain, and QoL (EQ-5D) at baseline, 18 and 36 months follow-up (last-observation-carried-forward (LOCF) and mixed-models-for-repeated-measures (MMRM).
  
  
  RESULTS
  One hundred and sixteen rheumatologists included 309 patients, of whom 290 (93.9%) had at least one follow-up visit. Women's mean age (standard deviation) was 74.5 years (7.4) and 296 (95.8%) had greater or equal to two vertebral fractures prior to teriparatide initiation. Clinical fracture incidence, mainly vertebral fractures, decreased around 6 months after teriparatide initiation, and was sustained at 36 months (P=0.013) when most patients were treated by anti-resorptives. Back pain and EQ-5D measures improved significantly at 18 and 36 months (P<0.0001) in the LOCF analyses but did not improve in the EQ-5D VAS measure after covariate adjustment in the MMRM model. Median treatment duration was 17.4 months.
  
  
  CONCLUSIONS
  French women initiating teriparatide in routine care had severe osteoporosis and showed good treatment persistence, consistent with France's insurance reimbursement criteria. Improvements in fracture risk and back pain began soon after treatment and was maintained at 36 months follow-up.
authors.affiliation: Rheumatology Department, Groupe Hospitalier Paris Saint-Joseph, Paris, France. Electronic address: grajzbaum@hpsj.fr.
authors.forename: Gerald
authors.initials: G
authors.lastname: Rajzbaum
authors.affiliation: Rheumatology Department, Centre Hospitalier Universitaire, Amiens, France.
authors.forename: Franck
authors.initials: F
authors.lastname: Grados
authors.affiliation: Lilly France, Neuilly, France.
authors.forename: David
authors.initials: D
authors.lastname: Evans
authors.affiliation: Lilly France, Neuilly, France.
authors.forename: Soyi
authors.initials: S
authors.lastname: Liu-Leage
authors.affiliation: Lilly Research Centre, Vienna, Austria.
authors.forename: Helmut
authors.initials: H
authors.lastname: Petto
authors.affiliation: Lilly France, Neuilly, France.
authors.forename: Béatrice
authors.initials: B
authors.lastname: Augendre-Ferrante
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001416:Back Pain / Q000209:etiology; D050071:Bone Density Conservation Agents / Q000627:therapeutic use*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D055118:Medication Adherence; D008875:Middle Aged; D015663:Osteoporosis, Postmenopausal / Q000150:complications / Q000188:drug therapy*; D011788:Quality of Life; D016103:Spinal Fractures / Q000209:etiology / Q000517:prevention & control*; D019379:Teriparatide / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D050071:Bone Density Conservation Agents; D019379:Teriparatide
keywords: Back pain; Fractures; Osteoporosis; Quality of life; Teriparatide